FDA Medical Device Recalls (openFDA)
Bausch & Lomb Inc: OPTIMA FW (polymacon) Visibility Tinted Contact Lenses, labeled as -2.25D, 8.7 mm. Responsible firm on the label: Bausch & Lomb Inc., Rochester, NY 14692. Each box contains six lenses.
- Recall number
- Z-0348-03
- Recalling firm
- Bausch & Lomb Inc
- Product
- OPTIMA FW (polymacon) Visibility Tinted Contact Lenses, labeled as -2.25D, 8.7 mm. Responsible firm on the label: Bausch & Lomb Inc., Rochester, NY 14692. Each box contains six lenses.
- Status
- Terminated
- Initiated
- 2002-11-26
- Posted
- 2002-12-19
- Terminated
- 2003-06-23
- Reason
- Lenses labeled as -2.25 diopter contain -0.75 diopter lenses.
- Root cause
- Other
- Action
- Letters dated 12/2/02 issued to distributors and practitioners requesting return of the affected lot.
- Quantity
- 2,081 / 6-packs
- Distribution
- Nationwide distribution.
- Lot, serial or model codes
- Lot R21000211
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LPM
- Firm FEI
- 1317628
- Firm city
- Rochester
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28